ACR Safety Guidelines 2004

8/12/2019 ACR Safety Guidelines 2004

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ACR WHITE PAPER ON MAGNETIC RESONANCE (MR) SAFETYCombined Papers of 2002 and 2004

INTRODUCTION

There are potential risks in the MR environment, not only for the patient,1,2but also for the accompanying

family members, attending health care professionals, and others who find themselves only occasionally or

rarely in the magnetic fields of MR scanners, such as security or housekeeping personnel, firefighters,

police, etc. There have been reports in the medical literature and print media detailing MRI adverse

incidents involving patients, equipment, and personnel that spotlighted the need for a safety review by anexpert panel. The following is the combined paper of 2 reports3,4issued by the American College of

Radiology Blue Ribbon Panel on MR Safety, chaired by Emanuel Kanal, MD, FACR. The panel

originally met in November 2001 and was charged with reviewing the existing MR safe practices and

guidelines5-9and issuing new ones as appropriate for MR examinations. The panel consisted of thefollowing members: A. James Barkovich, MD, Charlotte Bell, MD (Anesthesia Patient Safety

Foundation), James P. Borgstede, MD, FACR, William G. Bradley, MD, PhD, FACR, Joel Felmlee, PhD,

Jerry W. Froelich, MD, Ellisa M. Kaminski, RT(R)(MR), Emanuel Kanal, MD, FACR, Elaine K. Keeler,

PhD (NEMA), James W. Lester, MD, Elizabeth Scoumis, RN, BSN, Loren A. Zaremba, PhD (FDA),

Jeffrey Hayden (ACR staff), and Marie D. Zinninger (ACR staff). Upon Dr Keelers retirement, Shawn

Etheridge was appointed to represent NEMA.

After reviewing substantial feedback from the field and installed base, as well as changes that had

transpired throughout the MR industry in the interim, the panel reconvened in 2002 and 2003 and agreed

to several modifications and updates to the original document.

The following MR safe practice guidelines document, which incorporates both prior papers, is intended to

be used as template for MR facilities to follow in the development of an MR safety program. These MR

safe practice guidelines were developed to help guide MR practitioners regarding these issues and to

provide a basis for them to develop and implement their own MR policies and practices. It is intended that

these MR safe practice guidelines (and the policies and procedures to which they give rise) be reviewed

and updated on a regular basis as the field of MR safety continues to evolve.

This white paper does not attempt to deal with all aspects of MR safety, but rather those that apply to an

already installed, active site, whether a clinical or research facility. With the increasing advent and use of

3.0-T and higher strength magnets, users need to recognize that one should never assume MR

compatibility or safety information about a device if it is not clearly documented in writing. Decisions

based on published MR safety and compatibility claims should recognize that all such claims apply only

to specifically tested conditions, such as static magnetic field strengths, static gradient magnetic field

strengths and spatial distributions, and the strengths and rates of change of gradient and radiofrequency

(RF) magnetic fields.

Finally, there is a whole host of other issues that should be considered during the site-planning stages andthat is not dealt with in this manuscript. These include, among many others, cryogen emergency vent

locations and pathways, 5-G linesiting considerations, patient access pathways, and considerations

regarding fringe field blooming that may result in the event there is a failure of an actively shielded MRI

system. These issues, and many others, should be reviewed with those experienced in MR site planning

and familiar with the patient safety and patient flow considerations prior to committing construction to a

specific site design. In this regard, enlisting the assistance of an architectural firm experienced in thisarea, and doing so early in the design stages of the planning process, may prove most valuable.

It remains the intent of the ACR that these MR safe practice guidelines will prove helpful as the field of

MRI continues to evolve and mature, providing MR services that are among the most powerful, yet safest,

of all diagnostic procedures to be developed in the history of modern medicine.

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ACR Magnetic Resonance Safe Practice Guidelines

Combined Papers of 2002 and 2004

A. Establish, Implement, and Maintain Current MR Safety Policies and Procedures

1. All clinical and research MR sites should maintain MR safety policies and procedures, which areto be established, implemented, maintained, and routinely reviewed and updated, as appropriate.

The level of compliance by staff will be assessed and documented annually. The policies and

procedures manual should be readily available to the MR professionals on site at all times of

operation.

2. These policies and procedures should also be reviewed concurrently with the introduction of any

significant changes in the safety parameters of the MR environment of the site (eg, adding faster

or stronger gradient capabilities or higher RF duty cycle studies) and updated as needed. In this

review process, national and international standards and recommendations should be taken into

consideration prior to establishing local guidelines, policies, and procedures.

3. Each site will name an MR medical director whose responsibilities will include ensuring that

these MR safe practice guidelines are established and maintained as current and appropriate forthe site. It is the responsibility of the sites administration to ensure that the policies and

procedures that result from these MR safe practice guidelines are implemented and adhered to at

all times by all of the sites personnel.

4. Procedures should be in place to ensure that any and all adverse events, MR safety incidents, or

near incidents that occur in the MR site are reported to the medical director in a timely fashion

(eg, within 24 hours, or 1 business day, of their occurrence) and are used in continuous quality

improvement efforts.

B. Static Magnetic Field Issues: Site Access Restriction

1. Zoning:

The MR site is conceptually divided into 4 zones (see Figure 1 and Appendix 1):

a. Zone I: This region includes all areas that are freely accessible to the general public. This area

is typically outside the MR environment itself and is the area through which patients, health

care personnel, and other employees of the MR site access the MR environment.

b. Zone II: This area is the interface between the publicly accessible, uncontrolled Zone I and

the strictly controlled Zones III and IV. Typically, patients are greeted in Zone II and are not

free to move throughout Zone II at will, but rather are under the supervision of MR personnel

(see section B.2.b, below). It is in Zone II that the answers to MR-screening questions, patient

histories, medical insurance questions, etc are typically obtained.

c. Zone III: This area is the region in which free access by unscreened non-MR personnel or

ferromagnetic objects or equipment can result in serious injury or death as a result ofinteractions between the individuals or equipment and the MR scanners particular

environment. These interactions include, but are not limited to, those involving the MR

scanners static and time-varying magnetic fields. All access to Zone III is to be strictly

restricted, with access to regions within it (including Zone IV, see below) controlled by, and

entirely under the supervision of, MR personnel (see section B.2.b, below). Specifically

identified MR personnel (typicallybut not necessarily onlythe MR technologists) are to

be charged with ensuring that this MR safe practice guideline is strictly adhered to for the

safety of the patients and other non-MR personnel, the health care personnel, and the

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equipment itself. This function of the MR personnel is directly under the authority and

responsibility of the MR medical director or the level 2designated (see section B.2.b, below)

physician of the day for the MR site.

Zone III should be physically restricted from general public access by, for example, key

locks, passkey locking systems, or any other reliable, physically restricting method that can

differentiate between MR personnel and non-MR personnel. The use of combination locks isdiscouraged as combinations often become more widely distributed than initially intended,

resulting in site restriction violations being more likely with these devices. Only MR

personnel shall be provided free access, such as the access keys or passkeys, to Zone III.

There should be noexceptions to this guideline. Specifically, this includes hospital or site

administration, physician, security, and other non-MR personnel (see section B.2.c, below).

Non-MR personnel are not to be provided with independent Zone III access until such time as

they undergo the proper education and training to become MR personnel themselves. Zone

III, or at the very least the area within it wherein the static magnetic fields strength exceeds 5

G, should be demarcated and clearly marked as being potentially hazardous.

d. Zone IV: This area is synonymous with the MR scanner magnet room itself, ie, the physical

confines of the room within which the MR scanner is located. Zone IV, by definition, willalways be located within Zone III, as it is the MR magnet and its associated magnetic field

that generates the existence of Zone III. Zone IV should also be demarcated and clearly

marked as being potentially hazardous due to the presence of very strong magnetic fields. As

part of the Zone IV site restriction, all MR installations should provide for direct visual

observation by level 2 MR personnel to access pathways into Zone IV. By means of

illustration only, the MR technologists would be able to directly observe and control, via line

of site or via video monitors, the entrances or access corridors to Zone IV from their normal

positions when stationed at their desks in the scan control room.

Zone IV should be clearly marked with a red light and lighted sign stating, the magnet is

on. Except for resistive systems, this red light and sign should be illuminated at all times and

should be provided with a backup energy source to continue to illuminate for at least 24 hours

in the event of a loss of power to the site.

In case of cardiac or respiratory arrest or other medical emergency within Zone IV for which

emergent medical intervention or resuscitation is required, appropriately trained and certified

MR personnel should immediately initiate basic life support or CPR as required by the

situation whilethe patient is being emergently removed from Zone IV to a predetermined,

magnetically safe location.Allpriorities should be focused on stabilizing (eg, basic lifesupport with cardiac compressions and manual ventilation) and then evacuating the patient as

rapidly and safely as possible from the magnetic environment that might restrict safe

resuscitative efforts.

Further, for logistical safety reasons, the patient should always be moved from Zone IV to the

prospectively identified location where full resuscitative efforts are to continue.

Quenching the magnet (for superconducting systems only) is not routinely advised for cardiac

or respiratory arrest or other medical emergency, since quenching the magnet and having the

magnetic field dissipate could easily take more than a minute. Furthermore, as quenching a

magnet can theoretically be hazardous, ideally one should evacuate the magnet room, when

possible, for an intentional quench. One should rather use that time wisely to initiate life

support measures while moving the patient from Zone IV to a location where the strength of

the magnetic field is insufficient to be a medical concern. Zones III and IV site access

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restriction mustbe maintained during resuscitations and other emergent situations for the

protection of all involved.

2. MR personnel and non-MR personnel (see Appendix 1):

a. All individuals working within at least Zone III of the MR environment should be

documented as having successfully completed at least one of the MR safety live lectures or

prerecorded presentations approved by the MR medical director. Attendance should be

repeated at least annually, and appropriate documentation should be provided to confirm

these ongoing educational efforts. These individuals shall be referred to henceforth as MR

personnel.

b. There are 2 levels of MR personnel:

(1) Level 1 MR personnel: Those who have passed minimal safety educational efforts to

ensure their own safety as they work within Zone III will be referred to henceforth as

level 1 MR personnel.

(2) Level 2 MR personnel: Those who have been more extensively trained and educated in

the broader aspects of MR safety issues, including, for example, issues related to the

potential for thermal loading or burns and direct neuromuscular excitation from rapidlychanging gradients, will be referred to henceforth as level 2 MR personnel. It is the

responsibility of the MR medical director not only to identify the necessary training, but

also to identify those individuals who qualify as level 2 MR personnel. It is understood

that the medical director will have the necessary education and experience in MR safety

to qualify as level 2 MR personnel.

c. All those not having successfully complied with these MR safety instruction guidelines shall

be referred to henceforth as non-MR personnel. Specifically, non-MR personnel will be the

terminology used to refer to any individual or group who has not within the previous 12

months undergone the designated formal training in MR safety issues defined by the MR

safety director of that installation.

3. Patient and non-MR personnel screening:

a. Allnon-MR personnel wishing to enter Zone III must first pass an MR safetyscreening

process. Only MR personnel are authorized to perform an MR safety screen prior to

permitting non-MR personnel into Zone III.

b. The screening process and screening forms for patients, non-MR personnel, and MR

personnel should be essentially identical. Specifically, one should not assume that non-MR

personnel, health care practitioners, or MR personnel will not enter the bore of the MR

imager during the MRI process.

This might be the case if a pediatric patient cries for his mother, who then leans into the bore,

or if the anesthetist leans into the bore to manually ventilate a patient in the event of a

problem.

c. Metal detectors:

The usage of metal detectors in MR environments is notrecommended. Reasons for this

recommendation include, among others:

(1) They have variedand variablesensitivity settings.

(2) The skills of the operators can vary.

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(3) Todays metal detectors cannot detect, for example, a 23-mm, potentially dangerous

ferromagnetic metal fragment in the orbit or near the spinal cord or heart.

(4) Todays metal detectors do not differentiate between ferromagnetic and

nonferromagnetic metallic objects, implants, or foreign bodies.

(5) Metal detectors should not be necessary for the detection of large metallic objects, such

as oxygen tanks on the gurney with the patients. These objects are fully expected to be

detectedand physically excludedduring the routine patient-screening process.

d. Non-MR personnel should be accompanied by, or under the immediate supervision of and in

visual and verbal contact with, one specifically identified level 2 MR person for the entirety

of their duration within Zone III or IV. However, it is acceptable to have them in a changing

room or restroom in Zone III without visual contact as long as the personnel and the patient

can communicate verbally with each other.

Level 1 MR personnel are permitted unaccompanied access throughout Zones III and IV.

Level 1 MR personnel are also explicitly permitted to be responsible for accompanying non-

MR personnel into and throughout Zone III, excluding Zone IV. However, level 1 MR

personnel are notpermitted to directly admit, or be designated responsible for, non-MRpersonnel in Zone IV.

In the event of a shift change, lunch break, etc, no level 2 MR personnel shall relinquish their

responsibility to supervise non-MR personnel still within Zone III or IV until such

supervision has been formally transferred to another of the level 2 MR personnel.

e. Nonemergent patients should be MR safetyscreened on site by a minimum of 2 separate

individuals. At least one of these individuals should be level 2 MR personnel. At least one of

these 2 screens should be performed verbally or interactively.

Emergent patients and their accompanying non-MR personnel may be screened only once,

provided the screening individual is level 2 MR personnel. There should be no exceptions to

this.

f. Any individual undergoing an MR procedure must remove all readily removable metallic

personal belongings and devices on or in them, eg, watches, jewelry, pagers, cell phones,

body piercings (if removable), contraceptive diaphragms, metallic drug-delivery patches (see

section I), cosmetics containing metallic particles (such as eye makeup), and clothing items

that may contain metallic fasteners, hooks, zippers, loose metallic components, or metallic

threads. It is therefore advisable to require patients or research subjects to wear a site-

supplied gown with no metal fasteners during the MR procedure when feasible. Inquiries

regarding drug-delivery patches or pads have led the panel to review this issue and comment

as noted in section I, below.

g. All patients and non-MR personnel with a history of potential ferromagnetic foreign object

penetration must undergo further investigation prior to being permitted entrance to Zone III.Examples of acceptable methods of screening include patient history, plain X-ray films, prior

CT or MR studies of the questioned anatomic area, or access to written documentation of the

type of implant or foreign object that might be present. Once positive identification has been

made as to the type of implant or foreign object that is within a patient, best effort

assessments should be made to identify the MR compatibility or MR safety of the implant or

object. Efforts at identification might include written testing on the implant prior to

implantation (preferred), product labeling regarding the implant or object, and peer-reviewed

publications regarding MR compatibility and MR safety testing of the make, model, or type

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of the object. MR safety testing would be of value only if the object or device had not been

altered since such testing had been published.

All patients who have a history of orbit trauma by a potential ferromagnetic foreign bodyfor

which they sought medical attentionare to have their orbits cleared by either plain X-ray orbit

films10,11(2 views) or by a radiologists review and assessment of contiguous cut prior CT or

MR images (obtained since the suspected traumatic event), if available.

h. Conscious, nonemergent patients and research and volunteer subjects are to complete written

MR safetyscreening questionnaires prior to their introduction to Zone III. Family or

guardians of nonresponsive patients or of patients who cannot reliably provide their own

medical histories are to complete a written MR safetyscreening questionnaire prior to their

introduction to Zone III. These completed questionnaires are then to be reviewed orally with

the patient, guardian, or research subject in their entirety prior to permitting the patient or

research subject to be cleared into Zone III.

The patient, guardian, or research subject as well as the screening MR staff member must

both sign the completed form. This form should then become part of the patients medical

record. No empty responses will be acceptedeach question mustbe answered with a yes

or no, or specific further information must be provided as requested. A sample pre-MRscreening form is provided (see Appendix 2). This is the minimum information to be

obtained; more may be added if the site so desires.

i. Screening of the patient or non-MR personnel with, or suspected of having, an intracranial

aneurysm clip should be performed per the separate MR safe practice guideline addressing

this particular topic (see section M, below).

j. Screening of patients for whom an MR examination is deemed clinically indicated or

necessary but who are unconscious or unresponsive or who cannot provide their own reliable

histories regarding prior possible exposure to surgery, trauma, or metallic foreign objects and

for whom such histories cannot be reliably obtained from others:

(1) If no reliable patient metal exposure history can be obtained, and if the requested MRexamination cannot reasonably wait until a reliable history might be obtained, it is

recommended that such patients be physically examined by level 2 MR personnel. All

areas of scars or deformities that might be anatomically indicative of an implant, such as

on the chest or spine region, and whose origins are unknown and which may have been

caused by ferromagnetic foreign bodies, implants, etc, should be subject to plain-film

radiography (if recently obtained plain films or CT or MR studies of such areas are not

already available). The investigation described above should be made to ensure there are

no potentially harmful embedded or implanted metallic foreign objects or devices. All

such patients should also undergo plain-film imaging of the skull or orbits and chest to

exclude metallic foreign objects (if recently obtained radiographic or MR information is

not already available).

(2) Monitoring patients in the MR scanner is sometimes necessary. The potential for thermal

injury from excessive RF power deposition exists. Sedated, anesthetized, or unconscious

patients may not be able to express symptoms of such injury. This potential for injury is

greater on especially higher field whole-body scanners (eg, 1 T and above). Much patient

monitoring information can be satisfactorily acquired via pulse oximetry or other means

without the utilization of electrocardiographic tracing and its inherent thermal injury

risks. Patients who require EKG monitoring and who are unconscious, sedated, or

anesthetized should be examined after each imaging sequence with potential

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repositioning of the EKG leads and any other electrically conductive material with which

the patient is in contact. Alternatively, cold compresses or ice packs could be placed upon

all necessary electrically conductive material that touches the patient during scanning.

k. Final determination of whether or not to scan any given patient with any given implant,

foreign body, etc is to be made by the level 2designated, attending MR radiologist, the MR

medical director, or specifically designated level 2 MR personnel following criteria foracceptability predetermined by the medical director.

l. All non-MR personnel (eg, patients, volunteers, and varied site employees and professionals)

with implanted cardiac pacemakers, autodefibrillators, diaphragmatic pacemakers, or other

electromechanically activated devices upon which the non-MR personnel is dependent should

be precluded from Zone IV and physically restrained from the 5-G line unless specifically

cleared in writing by a level 2designated attending radiologist or the medical director of the

MR site. In such circumstances, specific defending risk-benefit rationale should be provided

in writing and signed by the authorizing radiologist.

Should it be determined that non-MR personnel wishing to accompany a patient into an MR

scan room require their orbits to be cleared by plain-film radiography, a radiologist must first

discuss with the non-MR personnel that plain X-ray films of their orbits are required prior topermitting them access to the MR scan room. Should they still wish to proceed with access to

Zone IV or within the 5-G line, and should the attending radiologist deem it medically

advisable that they do so (eg, for the care of their child about to undergo an MR study),

written informed consent should be provided by these accompanying non-MR personnel prior

to undergoing X-ray examination of their orbits.

m. MR scanning of patients, prisoners, or parolees with metallic prisoner-restraining devices or

RF ID or tracking bracelets could lead to theoretical adverse events, including: (1)

ferromagnetic attractive effects and resultant patient injury, (2) possible ferromagnetic

attractive effects and potential damage to the device or its battery pack, (3) RF interference

with the MRI study and secondary image artifact, (4) RF interference with the functionality

of the device, (5) RF power deposition and heating of the bracelet or tagging device or its

circuitry and secondary patient injury (if the bracelet would be in the anatomic volume of the

RF transmitter coil being imaged). Therefore, in cases where requested to scan a patient,

prisoner, or parolee wearing RF tagging bracelets or metallic handcuffs or anklecuffs, request

that the patient be accompanied by the appropriate authorities who can and will remove the

restraining device prior to the MR study and be charged with its replacement following the

examination.

n. Firefighter, police, and security safety considerations: For the safety of firefighters and other

emergent services responding to an emergent call at the MR site, it is recommended that all

fire alarms, cardiac arrests, or other emergent service response calls originating from or

located in the MR site should be forwarded simultaneously to a specifically designated

individual from amongst the sites MR personnel. This individual should, if possible, be on

site prior to the arrival of the firefighters or emergent responders to ensure that they do nothave free access to Zone III or IV. The site might consider assigning appropriately trained

security personnel, who have been trained and designated as MR personnel, to respond to

such calls.

In any case, all MR sites should arrange to prospectively educate their local fire marshals,

firefighter associations, and police or security personnel about the potential hazards of

responding to emergencies in the MR suite.

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It should be stressed that, even in the presence of a true fire (or other emergency) in Zone III

or IV, the magnetic fields may be present and fully operational. Therefore, free access to

Zone III or IV by firefighters or other non-MR personnel with air tanks, axes, crowbars, other

firefighting equipment, guns, etc might prove catastrophic or even lethal to those responding

or others in the vicinity.

As part of the Zones III and IV restrictions, all MR sites must have readily accessible, clearlymarked, MR-compatible fire extinguishing equipment physically stored within Zone III or

IV. All nonMR-compatible fire extinguishers and other firefighting equipment should be

restricted from Zone III.

For superconducting magnets, the helium (and the nitrogen, as well, in older magnets) is not

flammable and does not pose a fire hazard directly. However, the liquid oxygen that can

result from the supercooled air in the vicinity of the released gases might well increase the

fire hazard in this area. If there are appropriately trained and knowledgeable MR personnel

available during an emergency to ensure emergency response personnel are kept out of the

MR scanner or magnet room and 5-G line, quenching the magnet during a response to an

emergency or fire should not be a requirement.

However,if the fire is in such a location that Zone III or IV needs to be entered for whateverreason by firefighters or emergency response personnel and their firefighting and emergent

equipment, such as air canisters, crowbars, axes, and defibrillators, a decision to quench a

superconducting magnet should be veryseriously considered to protect the health and lives of

the emergency response personnel. Should a quench be performed, appropriately designated

MR personnel still need to ensure that allnon-MR personnel (including and especially

emergency response personnel) continue to be restricted from Zones III and IV until the

designated MR personnel has personally verified that the static field is either no longer

detectable or at least sufficiently attenuated to no longer present a potential hazard to one

moving by it with, for example, large ferromagnetic objects such as oxygen tanks or axes.

For resistive systems, the magnetic field of the MR scanner should be shut down as

completely as possible and verified as such prior to permitting the emergency response

personnel access to Zone IV. For permanent, resistive, or hybrid systems whose magnetic

fields cannot be completely shut down, MR personnel should be available to warn the

emergency response personnel that a very powerful magnetic field is still operational in the

magnet room.

4. MR personnel screening:

All MR personnel are to undergo an MR-screening process as part of their employment interview

process to ensure their safety in the MR environment. For their own protection, and for the

protection of the non-MR personnel under their supervision, all MR personnel must immediately

report to the MR medical director any trauma, procedure, or surgery they experience or undergo

where a ferromagnetic metallic object or device may have been introduced within or on them.

This will permit appropriate screening to be performed on the employee to determine the safetyof permitting that MR personneldesignated employee into Zone III.

5. Device and object screening:

As part of the Zone III site restriction and equipment testing and clearing responsibilities, all sites

should have ready access to a strong handheld magnet (1000 G). This will enable the site to test

external, and even some superficial internal, devices or implants for the presence of grossly

detectable ferromagnetic attractive forces.

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C. MR Technologist

1. MR technologists should be ARRT registered technologists (RTs). Furthermore, all MR

technologists must be trained as level 2 MR personnel during their orientation, prior to being

permitted free access to Zone III.

2. All MR technologists will maintain current certification in American Heart Association basic life

support at the health care provider level.

3. Except for emergent coverage, there will be a minimum of 2 MR technologists or one MR

technologist and one other individual with the designation of MR personnel in the immediate

Zone II through Zone IV environment. For emergent coverage, the MR technologist can scan

with no other individuals in their Zone II through Zone IV environment as long as there is in-

house, ready emergent coverage by designated department of radiology MR personnel (eg,

radiology house staff or radiology attendings).

D. Pregnancy-Related Issues

1. Health care practitioner pregnancies:

Pregnant health care practitioners are permitted to work in and around the MR environmentthroughout all stages of their pregnancy.12Acceptable activities include, but are not limited to,

positioning patients, scanning, archiving, injecting contrast, and entering the MR scan room in

response to an emergency. Although permitted to work in and around the MR environment,

pregnant health care practitioners are requested not to remain within the MR scanner bore or

Zone IV during actual data acquisition or scanning.

2. Patient pregnancies:

a. Pregnant patients can be accepted to undergo MR scans at any stage of pregnancy if, in the

determination of a level 2 MR personneldesignated attending radiologist, the risk-benefit

ratio for the patient warrants that the study be performed. The radiologist should confer with

the referring physician and document the following in the radiology report or the patients

medical record:

(1) The information requested from the MR study cannot be acquired via nonionizing means

(eg, ultrasonography).

(2) The data is needed to potentially affect the care of the patient or fetus duringthe

pregnancy.

(3) The referring physician does not feel it is prudent to wait until the patient is no longer

pregnant to obtain this data.

b. MR contrast agents should notbe routinely provided to pregnant patients. This decision, too,

is one that must be made on a case-by-case basis by the covering level 2 MR personnel

designated attending radiologist who will assess the risk-benefit ratio for the particular

patient.

c. It is recommended that pregnant patients undergoing an MR examination provide written

informed consent to document that they understand the risks and benefits of the MR

procedure to be performed, are aware of the alternative diagnostic options available to them

(if any), and wish to proceed.

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E. Pediatric MR Safety Concerns

1. Sedation and monitoring issues:

Children form the largest group requiring sedation for MRI, largely because of their inability to

remain motionless during scans. Sedation protocols may vary from institution to institution

according to the procedures performed (diagnostic vs interventional), the complexity of the

patient population (healthy preschoolers vs premature infants), the method of sedation (mild

sedation vs general anesthesia), and the qualifications of the sedation provider.

Adherence to standards of care mandates following the sedation guidelines developed by the

American Academy of Pediatrics,13,14the American Society of Anesthesiologists,15and the Joint

Commission on Accreditation of Healthcare Organizations.16In addition, sedation providers must

comply with the protocols established by the individual state and the practicing institution. These

guidelines require the following provisions:

a. Preprocedural medical history and examination for each patient

b. Fasting guidelines appropriate for age

c. Uniform training and credentialing for sedation providers

d. Intraprocedural and postprocedural monitors with adapters appropriately sized for children

(compatible with the magnetic field)

e. Method of patient observation (window, camera)

f. Resuscitation equipment, including oxygen delivery and suction

g. Uniform system of record keeping and charting (with continuous assessment and recording of

vital signs)

h. Location and protocol for recovery and discharge

i. Quality assurance program that tracks complications and morbidityFor the neonatal and the young pediatric population, special attention is needed in monitoring

body temperature in addition to other vital signs. Temperature monitoring equipment that is

approved for use in the MR suite is becoming more readily available. Commercially available,

MR-approved neonatal isolation transport units and other warming devices are also available for

use during MR scans.

2. Pediatric screening issues:

Children may not be reliable historians and, especially for older children and teenagers, should be

questioned both in the presence of parents or guardians and separately to maximize the possibility

that all potential dangers are disclosed. Therefore, it is recommended that they be gowned before

entering Zone IV to help ensure no metallic objects, toys, etc inadvertently find their way into

Zone IV. Pillows, stuffed animals, and other comfort items brought from home represent real

risks and should be discouraged from entering Zone IV. If unavoidable, each should be carefully

checked with the powerful handheld magnet and perhaps again in the MR scanner prior topermitting the patient to enter Zone IV in order to ensure they do not contain any objectionable

metallic components.

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3. MR safety of accompanying family and personnel:

Although any age patient might request that others accompany them for their MR examination,

this is far more common in the pediatric population. Those accompanying or remaining with the

patient should be screened using the same criteria as anyone else entering Zone IV.

In general, it would be prudent to limit accompanying adults to a single individual. Only a

qualified, responsible MR physician should make screening criteria exceptions.

Hearing protection and MR-compatible chairs or stools are recommended for accompanying

family members within the MR scan room.

4. Fetal MR contrast agent safety concerns:

The decision to administer a gadolinium-based MR contrast agent to pregnant patients should be

accompanied by a well-documented and thoughtful risk-benefit analysis. This analysis should be

able to defend a decision to administer the contrast agent based on overwhelming potential

benefit to the patient or fetus outweighing the theoretical but potentially real risks of the long-

term exposure of the developing fetus to free gadolinium ions.

Studies have demonstrated that gadolinium-based MR contrast agents pass through the placentalbarrier and enter the fetal circulation. From here, they are filtered in the fetal kidneys and then

excreted into the amniotic fluid. In this location, the gadolinium-chelate molecules are in a

relatively protected space and may remain in the amniotic fluid for an indeterminate amount of

time before finally being reabsorbed and eliminated. As with any equilibrium situation involving

any dissociation constant, the longer the chelate molecule remains in this space, the greater the

potential for dissociation of the potentially toxic gadolinium ion from its chelate molecule. It is

unclear what impact such free gadolinium ions might have if they were to be released in any

quantity in the amniotic fluid. Certainly, deposition into the developing fetus would raise

concerns of possible secondary adverse effects.

As indicated before, but repeated for added emphasis, a documented, in-depth analysis of the

potential risks and benefits to the patient and her fetus is necessary in order to arrive at a

reasonable conclusion as to the clinical advisability of administering a gadolinium-based MR

contrast agent to any pregnant patient.

F. Time-Varying Gradient Magnetic FieldRelated Issues: Induced Voltages

Types of patients needing extra caution:

Patients with implanted or retained wires in anatomically or functionally sensitive areas (eg,

myocardium or epicardium, implanted electrodes in the brain) should be considered at higher

risk, especially from faster MRI sequences, such as echo planar imaging (which may be used in

such sequences as diffusion-weighted imaging, functional imaging, perfusion-weighted imaging,

MR angiographic imaging, etc). The decision to limit the dB/dt (rate of magnetic field change)

and maximum strength of the magnetic field of the gradient subsystems during the imaging of

such patients should be reviewed by the level 2 MR personneldesignated attending radiologistsupervising the case or patient.

G. Time-Varying Gradient Magnetic FieldRelated Issues: Auditory Considerations

1. All patients and volunteers should be offered and encouraged to use hearing protection prior to

undergoing any imaging in the MR scanners.

2. All patients or volunteers in whom research sequences are to be performed (ie, MR scan

sequences that have not yet been approved by the Food and Drug Administration) are to have

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hearing protective devices in placeprior to initiating any MR sequences. Without hearing

protection in place, MRI sequences that are not FDA approved should not be performed on

patients or volunteers.

H. Time-Varying Radiofrequency Magnetic FieldRelated Issues: Thermal

1. All unnecessary or unused electrically conductive materials should be removed from the MR

system before the onset of imaging. It is not sufficient merely to unplug or disconnect unused,

unnecessary electrically conductive material and leave it within the MR scanner with the patient

during imaging. All electrical connections, such as on-surface coil leads or monitoring devices,

must be visually checked by the scanning MR technologist prior to each scan to ensure the

integrity of the thermal and electrical insulation.

2. Electrical voltages and currents can be induced within electrically conductive materials that are

within the bore of the MR imager during the MR imaging process. This might result in the

heating of this material by resistive losses. This heat might be of a caliber sufficient to cause

injury to human tissue. Among the variables that determine the amount of induced voltage or

current is the consideration that the larger the diameter of the conductive loop the greater the

potential induced voltages or currents and, thus, the greater the potential for resultant thermal

injury to adjacent or contiguous patient tissue.

Therefore, when electrically conductive materials (wires, leads, implants, etc) are required to

remain within the bore of the MR scanner with the patient during imaging, care should be taken

to ensure no large-caliber, electrically conductive loops (including patient tissue; see section H.5,

below) are formed within the MR scanner during imaging. Furthermore, it is possible, with the

appropriate configuration, lead length, static magnetic field strength, and other settings, to

introduce resonant circuitry between the transmitted RF power and the lead. This could result in

very rapid and clinically significant lead heating, especially at the lead tips, in a matter of seconds

to a magnitude sufficient to result in tissue thermal injury or burns. This can also theoretically

occur with implanted leads or wires even when they are not connected to any other device at

either end. Thus, exposure of electrically conductive leads or wires to the RF-transmitted power

during MR scanning should only be performed with caution and with appropriate steps taken to

ensure significant lead or tissue heating does not result (see section H.9, below).

3. When electrically conductive materials are required to be within the bore of the MR scanner with

the patient during imaging, care should be taken to place thermal insulation (including air, pads,

etc) between the patient and the electrically conductive material while simultaneously attempting

to (as much as feasible) keep the electrical conductor from directly contacting the patient during

imaging. It is also appropriate to try to position the leads or wires as far as possible from the innerwalls of the MR scanner if the body coil is being used for RF transmission. When it is necessary

that electrically conductive leads directly contact the patient during imaging, consideration should

be given to prophylactic application of cold compresses or ice packs to such areas.

4. Depending on specific magnet designs, care may be needed to ensure that the patients tissues do

not directly come into contact with the inner bore of the MR imager during the MRI process. Thiscare is especially important for several higher-field MR scanners. The manufacturers of these

devices provide pads and other insulating devices for this purpose, and manufacturer guidelines

should be strictly adhered to for these units.

5. It is important to ensure the patients tissues do not form large conductive loops. Therefore, care

should be taken to ensure the patients arms or legs are not positioned in such a way as to form a

large caliber loop within the bore of the MR imager during the imaging process. For this reason,

it is preferable that patients be instructed not to cross their arms or legs in the MR scanner.

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6. Skin staples and superficial metallic sutures: Patients requested to undergo MR studies in whom

there are skin staples or superficial metallic sutures (SMS) may be permitted to undergo the MR

examination if the skin staples or SMS are not ferromagnetic and are not in the anatomic volume

of RF power deposition for the study to be performed. If the nonferromagnetic skin staples or

SMS are within the volume to be RF irradiated for the requested MR study, several precautions

are recommended:

a. Warn the patient and make sure they are especially aware of the possibility that they may

experience warmth or even burning along the skin staple or SMS distribution. The patient

should be instructed to report immediately if they experience warmth or burning sensations

during the study (and not, for example, to wait until the end of the knocking noise).

b. It is recommended that a cold compress or ice pack be placed along the skin staples or SMS if

this can be safely clinically accomplished during the MRI examination. This will help to

serve as a heat sink for any focal power deposition that may occur, thus decreasing the

likelihood of a clinically significant thermal injury or burn to adjacent tissue.

7. For patients with extensive or dark tattoos, including tattooed eyeliner, in order to decrease the

potential for RF heating of the tattooed tissue, it is recommended that cold compresses or ice

packs be placed on the tattooed areas and kept in place throughout the MRI process if thesetattoos are within the volume in which the body coil is being used for RF transmission. This

approach is especially appropriate if fast spin echo (or other high-RF-duty cycle) MRI sequences

are anticipated in the study. If another coil is being used for RF transmission, a decision must be

made if high RF-transmitted power is to be anticipated by the study protocol design. If so, then

the above precautions should be followed. Additionally, patients with tattoos that have been

placed within 48 hours prior to the pending MR examination should be advised of the potential

for smearing or smudging of the edges of the freshly placed tattoo.

8. The unconscious or unresponsive patient should have all attached leads covered with a cold

compress or ice pack at the lead attachment site for the duration of the MR study prior to the

initiation of scanning.

9. As noted above, it has been demonstrated that resonant circuitry can be established during MRIbetween the RF energies being transmitted and specific lengths of long, electrically conductive

wires or leads, which can thus act as efficient antennae. This can result in heating of the tips of

these wires or leads to temperatures in excess of 90C in a few seconds. Therefore, patients in

whom there are long, electrically conductive leads, such as Swan-Ganz thermodilution cardiac

outputcapable catheters or Foley catheters with electrically conductive leads, should be

considered at risk for MR studies if the body coil is to be used for RF transmission over theregion of the electrically conductive lead. This is especially true for higher-field systems and for

imaging protocols utilizing fast spin echo or other high-RF-duty cycle MRI sequences. Each such

patient should be reviewed and cleared by an attending level 2 radiologist, and a risk-benefit ratio

assessment should be performed prior to permitting them access to the MR scanner.

I. Drug-Delivery Patches and Pads

Some drug-delivery patches contain metallic foil. Scanning the region of the metallic foil may result

in thermal injury.17Since removal or repositioning can result in altering the patients dose,

consultation with the patients prescribing physician would be indicated in assessing how best to

manage the patient. If the metallic foil of the patch delivery system is positioned on the patient so that

it is in the volume of excitation of the transmitting RF coil, the case should be specifically reviewed

with the radiologist or physician covering the case. Alternative options may include placing an ice

pack directly on the patch. This solution may still substantially alter the rate of delivery or absorption

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of the medication to the patient (and be less comfortable to the patient, as well). This ramification

should therefore not be treated lightly, and a decision to proceed in this manner should only be made

by a knowledgeable radiologist attending the patient and with the concurrence of the referring

physician, as well.

If the patch is removed, a specific staff member should be given responsibility for ensuring that it is

replaced or repositioned.

J. Cryogen-Related Issues

1. For superconducting systems, in the event of a system quench, it is imperative that all personnel

and patients be evacuated from the MR scan room as quickly and as safely feasible and that the

site access be immediately restricted to all individuals until the arrival of the MR equipment

service personnel. This is especially so if cryogenic gases are observed to have vented partially or

completely into the scan room, as evidenced in part by the sudden appearance of white clouds

or fog around or above the MR scanner. As noted in section B.3.n above, it is especially

important to ensure all police and fire response personnel are restricted from entering the MR

scan room with their equipment (axes, air canisters, guns, etc) until it can be confirmed that the

magnetic field has been successfully dissipated, as there may still be considerable static magnetic

field present despite a quench or partial quench of the magnet.

2. It should be pointed out that room oxygen monitoring was discussed by the MR Blue Ribbon

Panel and rejected at this time because the present oxygen-monitoring technology was considered

by industry experts not to be sufficiently reliable to allow for continued operation during

situations of power outages, etc.

K. Claustrophobia, Anxiety, Sedation, Analgesia, and Anesthesia

Adult and pediatric patient anxiolysis, sedation, analgesia, and anesthesia for any reason should

follow established ACR,18,19American Society of Anesthesiologists,15,20-22and JCAHO standards.23

L. Contrast Agent Safety

1. Contrast agent administration issues:

No patient is to be administered prescription MR contrast agents without orders from a duly

licensed physician. Intravenous injectionqualified MR technologists may start and attend to

peripheral IV access lines if they have undergone the requisite site-specified training in peripheral

IV access and have demonstrated and documented appropriate proficiency in this area. IV-qualified MR technologists may administer FDA-approved gadolinium-based MR contrast agents

via peripheral IV routes as a bolus or as a slow or continuous injection, as directed by the orders

of a duly licensed site physician.

a. Administration of these agents is to be performed as per the ACR policy: The ACR approves

of the injection of contrast material and diagnostic levels of radiopharamceuticals by certified

and/or licensed radiologic technologists and radiologic nurses under the direction of a

radiologist or his or her physician designee who is personally and immediately available, ifthe practice is in compliance with institutional and state regulations. There must also be prior

written approval by the medical director of the radiology department /service of such

individuals; such approval process having followed established policies and procedures, and

the radiologic technologists and nurses who have been so approved maintain documentation

of continuing medical education related to materials injected and to the procedures being

performed. (Res 1-H, 1987, 1997)

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2. Prior contrast agent reaction issues:

a. According to the ACRManual on Contrast Media,Adverse events after intravenous

injection of gadolinium seem to be more common in patients who had previous reactions to

an MR contrast agent. In one study, 16 (21%) of 75 patients who had previous adverse

reactions to MR contrast agents reacted to subsequent injections of gadolinium. Patients with

asthma also seem to be more likely to have an adverse reaction to gadolinium. Patients withallergies also seemed to be at increased risk (~2.0-3.7 times, compared with patients without

allergies). Patients who have had adverse reactions to iodinated contrast media are more than

twice as likely to have an adverse reaction to gadolinium (6.3% of 857 patients).

b. At present there are no well-defined policies for patients who are considered to be at

increased risk for having adverse reaction to MR contrast agents; however, the following

recommendations are suggested: patients who have previously reacted to one MR agent can

be injected with another agent, if they are restudied, and at-risk patients can be pre-medicated

with corticosteroids and, occasionally, antihistamines.24

c. All patients with asthma, allergic respiratory histories, prior iodinated or gadolinium-based

contrast reactions, etc should be followed more closely as they are at a demonstrably higher

risk of adverse reaction.

M. Patients in Whom There Are or May Be Intracranial Aneurysm Clips

1. In the event it is unclear whether a patient does or does not have an aneurysm clip in place, plain

films should be obtained. Alternatively, if available, any cranial plain-film, CT, or MR

examination that may have been taken in the recent past (ie, subsequent to the suspected surgical

date) should be reviewed to assess for a possible intracranial aneurysm clip.

2. In the event that a patient is identified to have an intracranial aneurysm clip in place, the MR

examination should not be performed until it can be documented that the type of aneurysm clip

within that patient is MR safe or compatible. All documentation of types of implanted clips,dates, etc mustbe in writing and signed by a licensed physician. Phone or verbal histories and

histories provided by a nonphysician are not acceptable. Faxed copies of operative reports,physician statements, etc are acceptable as long as a legible physician signature accompanies the

requisite documentation. A written history of the clip having been appropriately tested for

ferromagnetic properties (and a description of the testing methodology used) prior to implantation

by the operating surgeon is also considered acceptable if the testing follows the deflection test

methodology established by the American Society of Testing and Materials.

3. All implanted intracranial aneurysm clips that are documented in writing to be composed of

titanium (either the commercially pure or the titanium alloy types) can be accepted for scanning

without any other testing.

4. All nontitanium intracranial aneurysm clips manufactured 1995 or later for which the

manufacturers product labeling continues to claim MR compatibility may be accepted for MR

scanning without further testing.

5. Clips manufactured prior to 1995 require either pretesting (per the American Society of Testing

and Materials deflection test methodology) prior to implantation or the individual review of a

previous MRI of the clip or brain in that particular case, if available. By assessing the size of the

artifact associated with the clip relative to the static field strength on which it was studied, the

sequence type, and the MRI parameters selected, an opinion may be issued by one of the sites

level 2 MR attending radiologists as to whether the clip demonstrates significant ferromagnetic

properties or not. Access to the MR scanner would then be based on that opinion.

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6. A patient with an aneurysm clip (or other implant) may have safely undergone a prior MR

examination at any given static magnetic field strength. This fact in and of itself isnot sufficient

evidence of the implants MR safety or compatibility and should notsolely be relied upon to

determine the MR safety or compatibility status of the aneurysm clip (or other implant).

Variations in static magnetic field strength, static magnetic field spatial gradient, orientation of

the aneurysm clip (or other implant) to the static magnetic field or static field gradient, rate ofmotion through the spatial static field gradient, etc are all variables that are virtually impossible to

control or reproduce. These variables may not have resulted in adverse events in one

circumstance but may result in significant injury or death on a subsequent exposure. For example,

a patient who went blind from interactions between the metallic foreign body in his retina and thespatial static fields of the MR scanner entered the magnet and underwent the entire MR

examination without difficulty; he went blind upon exiting the MR scanner at the completion of

the examination.

7. Barring availability of either pretesting or prior MRI data of the clip in question, a risk-benefit

assessment and review must be performed in each case individually. Further, for patients with

intracranial clips with no available ferromagnetic or imaging data, should the risk-benefit ratio

favor the performance of the MR study, the patient or guardian should provide written informed

consent that includes death as a potential risk of the MRI procedure prior to permitting that

patient to undergo an MR examination.

N. Patients in Whom There Are or May Be Cardiac Pacemakers or Implantable Cardioverter

Defibrillators

It is recommended that the presence of implanted cardiac pacemakers or implanted cardioverter

defibrillators (ICDs) be considered contraindicated for routine MRI. Should an exception be

considered, it should be done on a case-by-case and site-by-site basis and only if the site is manned

with individuals with the appropriate radiology and cardiology knowledge and expertise on hand.

Ideally, the nonemergent patient should be apprised of the risks associated with the procedure and

should provide prospective written informed consent prior to its initiation. Further, should any MRI

examination be contemplated for a patient with an implanted pacing device, it is recommended that

radiology and cardiology personnel and a fully stocked crash cart and defibrillator be on hand

throughout the procedure in case a significant arrhythmia develops during the examination and for

whatever reason does not terminate with the cessation of the MR study. All such patients should be

actively monitored for cardiac and respiratory function throughout the examination. At the conclusion

of the examination, the cardiologist or electrophysiologist should interrogate the pacemaker to

confirm that the function is consistent with the pre-examination state. The panel is unaware at this

time of any ICD devices that are designed to be safely exposed to intentional MR scanning. In fact,

there have been reports of ICD device malfunction after inadvertent exposure to MR scanning.

There have been numerous reports of patients with pacemakers who have undergone MR

examinations, both intentionally as well as inadvertently, without difficulty or apparent injury. There

have also been several patients who were inadvertently exposed to MR studies who have died during

the examination or very shortly thereafter. There is an increasing body of evidence documenting theability of the MRI process to produce, in specific cases and under certain circumstances, direct

cardiac stimulation and arrhythmias. It is theorized that such arrhythmogenesis and its severe

hypotensive sequelae were the cause of death in at least several of these patients, some of whom were

not pacemaker dependent prior to the MR examination. It is also becoming more apparent that the

primary cause of such arrhythmias seems to result from interactions between the pacemakers lead

circuitry and the RF power transmitted during the MRI process.

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Some have suggested that it might be possible to perform MRI examinations on patients with

implanted cardiac pacemakers as long as rigid guidelines were carefully defined and adhered to

throughout the imaging process. These include recommendations, among others, that ensure no

pacemaker-dependent patient is scanned, that the RF power transmitted during the MRI process is not

deposited over the volume that contains the pacemaker or its leads, etc. This guideline makes no

attempt to judge the scientific veracity of these observations or claims. However, it clearly recognizes

that, even if it is possible to safely perform MRI examinations on cardiac pacemaker patients, theexpertise necessary to safely do so is exceedingly rare throughout MR industry today.

The entire field of MR scanning of pacemaker patients is one that is exhibiting tremendous activity,

research, and growth of late. Fiber-optic pacemaker devices, coated or shielded leads and pacingdevices, and various other designs and configurations of MR pacing devices and leads are being

actively investigated in an to attempt to devise MR-safe cardiac pacemakers. It is therefore another

area within MR safety that bears close observation and frequent updates over the next few months

and years as progress continues to be made toward developing avenues that will enable pacemaker,

and eventually perhaps even ICD, patients to have safe access to the powerful diagnostic modality

that is MRI.

REFERENCES:

1. Chaljub G, Kramer LA, Johnson RF III, Johnson RF Jr, Singh H, Crow WN. Projectile cylinder

accidents resulting from the presence of ferromagnetic nitrous oxide or oxygen tanks in the MR suite.

AJR Am J Roentgenol.2001;177:27-30.

2. ECRI hazard report: patient death illustrates the importance of adhering to safety precautions in

magnetic resonance environments.Health Devices.2001;30:311-314.

3. Kanal E, Borgstede JP, Barkovich AJ, et al. American College of Radiology white paper on MR

safety.AJR Am J Roentgenol.2002;178:1335-1347.

4. Kanal E, Borgstede JP, Barkovich AJ, et al. American College of Radiology white paper on MR

safety: 2004 update and revisions.AJR Am J Roentgenol.2004;182:1111-1114.

5. Shellock FG, Kanal E. Policies, guidelines, and recommendations for MR imaging safety and patient

management. The SMRI Safety Committee.J Magn Reson Imaging.1991;1:97-101.

6. Kanal E, Shellock FG. Policies, guidelines and recommendations for MR imaging safety and patient

management. The SMRI Safety Committee.J Magn Reson Imaging.1992;2:247-248.

7. Shellock FG, Kanal E. Guidelines and recommendations for MR imaging safety and patient

management. III. Questionnaire for screening patients before MR procedures. The SMRI Safety

Committee.J Magn Reson Imaging.1994;4:749-751.

8. Magnetic resonance imaging monograph: safety and sedation.Practice Guidelines and Technical

Standards.Reston, Va: American of College Radiology; 1996.

9. ACR standard for performing and interpreting magnetic resonance imaging (MRI).PracticeGuidelines and Technical Standards.Reston, Va: American of College Radiology; 2000.

10. Jarvik JG, Ramsey S. Radiographic screening for orbital foreign bodies prior to MR imaging: is it

worth it?Am J Neuroradiol.2000;21:245-247.

11. Seidenwurm DJ, McDonnell CH III, Raghaven N, Breslau J. Cost utility analysis of radiographic

screening for an orbital foreign body before MR imaging.Am J Neuroradiol.2000;21:426-433.

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12. Kanal E, Gillen J, Evans JA, Savitz DA, Shellock FG. Survey of reproductive health among female

MR workers.Radiology.1993;187(2): 395-399.

13. American Academy of Pediatrics Committee on Drugs. Guidelines for monitoring and management

of pediatric patients during and after sedation for diagnostic and therapeutic procedures.Pediatrics.

1992;89:1110-1115.

14. American Academy of Pediatrics Committee on Drugs. Guidelines for monitoring and management

of pediatric patients during and after sedation for diagnostic and therapeutic procedures: addendum.

Pediatrics.2002;110:836-838.

15. Updated Practice Guidelines for Sedation and Analgesia by Non-anesthesiologists.Park Ridge, Ill:

American Society of Anesthesiologists; August 2001.

16. Standards and intents for sedation and anesthesia care. Comprehensive Accreditation Manual for

Hospitals.Chicago, Ill: Joint Commission on Accreditation of Healthcare Organizations; 2002.

Report No. TX 2-2.

17. Shellock FG.Pocket Guide to MR Procedures and Metallic Objects: Update 2001.Philadelphia, Pa:

Lippincott Williams and Wilkins; 2001:147-148.

18. ACR standard for adult sedation/analgesia.Practice Guidelines and Technical Standards.Reston, Va:

American of College Radiology; 2000.

19. ACR standard for pediatric sedation/analgesia.Practice Guidelines and Technical Standards.Reston,

Va: American of College Radiology; 1998.

20. Guidelines for Non-operating Room Anesthetizing Locations.Park Ridge, Ill: American Society of

Anesthesiologists; 1994.

21. Standards for Basic Anesthetic Monitoring.Park Ridge, Ill: American Society of Anesthesiologists;

1986,1998.

22. Standards for Post Anesthesia Care.Park Ridge, Ill: American Society of Anesthesiologists;

1988,1994.

23. Standards and intents for sedation and anesthesia care. Comprehensive Accreditation Manual for

Hospitals.Chicago, Ill: Joint Commission on Accreditation of Healthcare Organizations; 2001.

Report No. TX 2-2.4.1.

24. American College of Radiology Committee on Drugs and Contrast Media.Manual on Contrast

Media.4.1 ed. Reston, Va: American College of Radiology; 1998.

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Figure 1

Model MR Facility Zone Configuration

This figure is meant to represent an idealized sample floor plan, illustrating site access restriction

considerations. Other potential MR safety issues, such as magnet site planning related to fringe magnetic

field considerations, are not meant to be included herein.

See Appendix 1 for personnel and zone definitions.

Note: In any zone of the facility, there should be compliance with HIPAA regulations in regard to privacy

of patient information. However, in Zone III, there should be a privacy barrier so that unauthorized

persons cannot view the control panels.

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Appendix 1

PERSONNEL DEFINITIONS

Non-MR Personnel

Patients, visitors, or facility staff who do not meet the criteria of level 1 or 2 MR personnel will be

referred to as non-MR personnel. Specifically, non-MR personnel will be the terminology used to refer to

any individual or group who has not within the previous 12 months undergone the designated formaltraining in MR safety issues defined by the MR safety director of that installation.

Level 1 MR Personnel

Individuals who have passed minimal safety educational efforts to ensure their own safety as they work

within Zone III will be referred to as level 1 MR personnel (eg, MRI department office staff, patient

aides).

Level 2 MR Personnel

Individuals who have been more extensively trained and educated in the broader aspects of MR safety

issues, including, for example, issues related to the potential for thermal loading or burns and direct

neuromuscular excitation from rapidly changing gradients, will be referred to as level 2 MR personnel

(eg, MR technologists, radiologists, radiology department nursing staff).

ZONE DEFINITIONS

Zone I

This region includes all areas that are freely accessible to the general public. This area is typically outside

the MR environment itself and is the area through which patients, health care personnel, and other

employees of the MR site access the MR environment.

Zone II

This area is the interface between the publicly accessible, uncontrolled Zone I and the strictly controlled

Zone III (see below). Typically, patients are greeted in Zone II and are not free to move throughout Zone

II at will, but rather are under the supervision of MR personnel .It is in Zone II that the answers to MR-

screening questions, patient histories, medical insurance questions, etc are typically obtained.

Zone III

This area is the region in which free access by unscreened non-MR personnel or ferromagnetic objects or

equipment can result in serious injury or death as a result of interactions between the individuals or

equipment and the MR scanners particular environment. These interactions include, but are not limited

to, those involving the MR scanners static and time-varying magnetic fields. All access to Zone III is to

be strictly restricted, with access to regions within it (including Zone IV, see below) controlled by, and

entirely under the supervision of, MR personnel.

Zone IV

This area is synonymous with the MR scanner magnet room itself. Zone IV, by definition, will always be

located within Zone III, as it is the MR magnet and its associated magnetic field, which generates the

existence of Zone III.

Non-MR personnel should be accompanied by, or under the immediate supervision of and visual contact

with, one specifically identified level 2 MR person for the entirety of their duration within Zone III or IV.

Level 1 and 2 MR personnel may move freely about all zones.

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Appendix 2

Safety Screening Form

for

Magnetic Resonance (MR) Procedures

Date: _______________ Name (first middle last):

Female [ ] Male [ ] Age: _____ Date of birth: ___________ Height: _______ Weight:

Why are you having this examination (medical problem)?

Yes No

Have you ever had an MRI examination before and had a problem? ____ ____

If yes, please describe:

Have you ever had a surgical operation or procedure of any kind? ____ ____

If yes, list all prior surgeries and approximate dates:

Have you ever been injured by a metal object or foreign body (eg, bullet, BB, shrapnel)? ____ ____


Have you ever had an injury from a metal object in your eye (metal slivers, metal

shavings, other metal object)?

____ ____

If yes, did you seek medical attention? ____ ____

If yes, describe what was found:

Do you have a history of kidney disease, asthma, or other allergic respiratory disease? ____ ____

Do you have any drug allergies? ____ ____

If yes, please list drugs:

Have you ever received a contrast agent or X-ray dye used for MRI, CT, or other X-ray

or study?

____ ____

Have you ever had an X-ray dye or magnetic resonance imaging (MRI) contrast agent

allergic reaction?

____ ____


Are you pregnant or do you suspect you may be pregnant? ____ ____

Are you breast-feeding? ____ ____

Date of last menstrual period: _______________ Are you postmenopausal? ____ ____

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____ ____ Radiation seeds (eg, cancer treatment)

____ ____ Any implanted items (eg, pins, rods, screws, nails, plates, wires)

____ ____ Any hair accessories (eg, bobby pins, barrettes, clips)

____ ____ Jewelry

____ ____ Any other type of implanted item

Type:

Instructions for the Patient

1. You are urged to use the earplugs or headphones we supply during your MRI examination since some

patients may find the noise levels unacceptable, and the noise levels may affect your hearing.

2. Remove all jewelry (eg, necklaces, pins, rings).

3. Remove all hairpins, bobby pins, barrettes, clips, etc.

4. Remove all dentures, false teeth, and partial dental plates.

5. Remove hearing aides.

6. Remove eyeglasses.

7. Remove your watch, pager, cell phone, credit cards, bankcards, and all other cards with a magnetic

strip.

8. Remove body piercing objects.9. Use gown, if provided, or remove all clothing with metal fasteners, zippers, etc.

I attest that the above information is correct to the best of my knowledge. I have read and understand theentire contents of this form, and I have had the opportunity to ask questions regarding the information on

this form.

Patient signature:

MD/RN/RT signature: Date:

Print name of MD/RN/RT:

For MRI Office Use Only

Patient name:

Patient ID number: _______________ Referring physician:

Procedure: _________________________ Diagnosis:

Clinical History:

Hazard Checklist for MRI Personnel

Yes No

____ ____ Endotracheal tube

____ ____ Swan-ganz catheter

____ ____ Extra ventricular device

____ ____ Arterial line transducer

____ ____ Foley catheter with temperature sensor and/or metal clamp

____ ____ Rectal probe

____ ____ Esophageal probe

____ ____ Tracheotomy tube

____ ____ Guidewires

Documents

ACR Safety Guidelines 2004